設備
製造設備および試験設備。
設備2026年8月24日
Autoclave — Operational Qualification Checklist
Core OQ tests for a steam autoclave used in pharmaceutical sterilization.
1
設備2026年8月24日
Balance and Weighing Equipment — Calibration Frequency and Tolerance
How to set risk-based calibration frequency and tolerance for analytical and production balances.
2
設備2026年8月24日
Blister Packaging Machine — URS for New Equipment Purchase
What to specify when writing a URS for a new blister packaging line.
1
設備2026年8月24日
Clean-in-Place (CIP) Systems — Validation Approach
How CIP systems are validated to consistently remove residues between manufacturing batches.
設備2026年8月24日
Dissolution Apparatus — USP Apparatus 1/2 Qualification Requirements
Mechanical calibration and performance verification requirements for USP Apparatus 1 (basket) and 2 (paddle).
7
設備2026年8月24日
Fluid Bed Dryer — Performance Qualification Approach
How PQ demonstrates a fluid bed dryer performs consistently under real production conditions.
設備2026年8月24日
Freeze Dryer (Lyophilizer) — Process Parameters and Qualification
Key process parameters for freeze-drying equipment and how they connect to qualification and cycle development.
設備2026年8月24日
HPLC System — User Requirement Specification (URS) Template
Key sections and considerations when drafting a URS for a new HPLC system purchase.
設備2026年8月24日
Karl Fischer Titrator — Calibration and Maintenance Guide
Routine calibration checks and maintenance practices that keep Karl Fischer water-content results reliable.
設備2026年8月24日
Tablet Compression Machine — Installation Qualification Protocol
What an IQ protocol for a tablet press should verify before moving to operational qualification.